 EARLY TIMES REPORT
JAMMU, Sept 4: A National CME-cum-workshop and training on new clinical trial rule 2019, Good Clinical Practices and IEC was conducted by Indian Society for Rational Therapeutics- J&K under aegis of ISRPT in collaboration with ASCOMS & Hospital, Sidhra Jammu, with the assistance and collaboration of Department of Pharmacology GMC Jammu. Dr Shashi Sudhan Sharma (PMC/Dean GMC, Jammu) was the chief guest on the occasion. More than 460 offline and Online delegates and esteemed faculty of national and International repute participated in the event. IIT, Jammu, IEC GMC Kathua, IEC, GMC Rajouri, IEC ASCOMS participated CME as offline node. Dr YK Gupta Former Professor and Head of Department of Pharmacology, President AIIMS, Jammu and Bhopal, was the guest of honour. Dr Pavan Malhotra, Director Principal ASCOMS, Jammu–organizing chairperson, welcomed the delegates and esteemed faculty of the said CME and said that New Drugs and Clinical Trials (NDCT) Rules, 2019 are now regulating conduct of clinical trial on new drugs, investigational new drugs for human use, bioequivalence study, bioavailability study. Dr Kuldeep Sharma, Former Dean, Faculty of Life Sciences, & Head Department of Zoology, University of Jammu, Chairperson IEC, GMC Jammu, IIT Jammu and ASCOMS, said that IEC registration is now mandatory with CDSCO and DHR, ICMR.
Dr Vishal Tandon Organizing secretary in his lecture said that main responsibility of Institutional Ethics Committee is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial. Bharti Bachloo Assistant Drugs Controller (I), Jammu was the observer and guest speaker in the CME.
Dr Bikash Medhi Professor, Pharmacology PGIMER, who is in technical and advisory committees of CDSCO and ICMR, maintained that good clinical trial practices should be strictly enforced and monitored by IEC.
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